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“With regards to the substance, to have that IND quantity might be a large amount of operate,” Halpern claimed.
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This protocol is judged by an institutional evaluation board, an unbiased team that critiques any scientific trials involving human beings. If a research consists of a Timetable I drug, when the board approves the protocol as ethical, the scientists have to make an application for an investigational new drug (IND) selection in the FDA.